Tympanostomy tube and placement device

ABSTRACT

A tympanostomy tube placement device has a needle with a tip, and a retainer at the needle tip. The retainer is within and retains by pulling radially inwardly a tympanostomy tube distal flange in a folded configuration extending distally. Movement of the needle tip in the proximal direction causes the adhesive bond to break and the distal flange releases to an unconstrained deployed position. Due to the axial folding of the distal flange its radial dimension does not affect deployment through the membrane.

INTRODUCTION Field of the Invention

The invention relates to tympanostomy tubes and applicators or“placement devices” for deploying them.

Prior Art Discussion

A tympanostomy tube applicator is a minimally-invasive tool that aidsphysicians in treating patients suffering from ear conditions forexample Otitis Media, who require tympanostomy tube placement. Thecondition is treated by inserting a tympanostomy tube across thetympanic membrane (or, “ear drum”) to ventilate the middle ear space andequalize the pressure between the middle and outer ear. Tympanostomytube insertion is the main reason why children undergo surgery with ageneral anaesthetic. An applicator allows tympanostomy tubes to beplaced safety and quickly in patients tympanic membrane.

WO2014/075949 (Cork Institute of Technology) and WO2011/008948(Acclarent) describe such applicators. In these devices the tip createsan incision in the tympanic membrane and ejects a tympanostomy tube intothe membrane. The tube in WO2014/075949 is restrained by sleevessurrounding it and a knife pulls through to deploy the tube.WO2011/008948 (Acclarent) describes a tube delivery system in which atympanostomy tube is restrained by sleeves surrounding it so that itsflanges lie axially.

The invention is directed towards providing an applicator for effectivedeployment of a tube; and another object is to allow placement of tubeswith good versatility in choice of size of distal flange to provide awide range of dwell times.

SUMMARY OF THE INVENTION

We describe a tympanostomy tube applicator comprising a needle with atip and a stem, and a retainer on the needle stem. The retainer isconfigured to fit within and retain a tympanostomy tube distal flange ina folded configuration having a direction with a primarily axialcomponent such that movement of the needle tip causes the distal flangeto release from the retainer to a deployed position having a directionwith a primarily radial component.

The term “applicator” is used in this document, and this is equivalentto the term “placement device”, its purpose being to allow a surgeon toplace the tube in the membrane.

Preferably, the needle is arranged to move axially to cause release ofthe tube distal flange from the retainer.

Preferably, the retainer comprises recesses for retaining wings of awinged tube distal flange. This is an effective way of allowing theretainer to, pre-deployment, pull the flange wings into the axial ornear-axial position, from within.

The applicator may comprise a stop surface to stop axial movement of atube proximal flange, such that the retainer squeezes the tube againstthe stop surface to cause the distal flange to release during axialmovement of the needle in the proximal direction. The stop surface maybe on a sleeve into which the needle is inserted.

The retainer may include a discrete component on the needle. Theretainer discrete component may be of plastics material.

Preferably, the retainer discrete component has a through-hole throughwhich the needle stem extends, and the component is in contact with theneedle tip.

Preferably, the retainer is arranged to retain the distal flange in thepre-deployment folded configuration by at least adhesive.

The retainer may be arranged to retain the distal flange in thepre-deployment folded configuration by at least mechanical engagement.The retainer may comprise fingers engaging eyelets on the tube distalflange.

The retainer may comprise dovetail or slot features for engagement witha tube distal flange.

The retainer may be adapted to engage with a tube by welding ormagnetism for retaining the distal flange in the folded configuration.

The applicator may further comprise a tympanostomy tube having aproximal flange, a bridge with a lumen, and a distal flange, in whichsaid tube is mounted on the needle with the needle stem extendingthrough the lumen and with said distal flange folded and retained insaid folded position by the retainer. It is advantageous that theapplicator is pre-loaded with a tube ready for deployment

The applicator may be a cartridge for attachment to a handle with amechanism for movement of said needle.

The applicator may further comprise an integral handle with a mechanismfor movement of the needle.

We also describe a tympanostomy tube comprising a proximal flange, abridge, a distal flange, and a lumen, wherein the distal flange isconfigured to be retained at a folded orientation with a directionhaving a primarily axial component and to release to a deployed positionhaving a direction with a primarily radial component upon movement of aretainer located radially within the distal flange.

Preferably, the distal flange comprises a plurality of wings.

The distal flange may be configured to have an angle to axial in thefolded position in the range of 0° to +/−20°.

Preferably, the distal flange is configured to have an angle to axial inthe unconstrained deployed position in the range of 40° to 140°.

The bridge may be of a material which is resilient to allow a needle tipof larger diameter than the lumen to pass through.

The distal flange may have two wings or three wings or four wings forexample.

The distal flange may be annular-shape, optionally with radial cut-outs.

The distal flange may comprise at least one mechanical engagement partarranged to engage mechanically a needle retainer, and each mechanicalengagement part may be an eyelet for receiving a retainer part or a tabfor engagement behind or within a slot or eyelet of the retainer.

The distal flange may include an insert of a material which is differentfrom surrounding material, said insert being configured for attachmentto a retainer by, for example, welding, magnetism, or adhesive.

We also describe a method of deploying a tympanostomy tube across atympanic membrane, in which:

-   -   the tube comprises a proximal flange, a bridge, a distal flange,        and a lumen,    -   the method is performed with an applicator comprising a needle        with a stem and a tip, and a retainer on the needle stem    -   the tube is mounted on the retainer with the needle stem through        the tube lumen, and the tube distal flange is retained in a        folded position to have a primarily axial component facing        distally;        the method comprising the steps of:    -   piercing the tympanic membrane with the needle tip and locating        the needle so that the tube distal flange is distal of the        membrane and the tube bridge passes through the membrane,    -   moving the retainer relative to the tube to cause separation of        the tube distal flange from the retainer, freeing the distal        flange to spring out on a radial orientation unconstrained.

Preferably, the needle is moved axially to release the distal flange.Preferably, the needle movement is in the proximal direction.

The tube distal flange may be adhered to or mechanically engaged with aretainer on the needle.

The needle movement may be rotational in addition to or instead of beingaxial.

The tube distal flange may be retained at least by adhesive and anadhesive bond is broken during needle withdrawal.

The tube distal flange may be retained at least by mechanicalengagement.

The tube distal flange may include parts which mechanically engage theretainer and/or the needle and are sheared upon retraction of theneedle, and said parts may include eyelets.

The tube distal flange may be retained at least by welding.

The tube distal flange may be retained at least by magnetism.

Additional Statements According to the invention there is provided atympanostomy tube applicator comprising:

a needle with a tip, and a retainer at the needle tip for retaining atympanostomy tube distal flange in a folded configuration with adirection having a primarily axial component such that movement of theneedle tip causes the distal flange to release to a deployed positionhaving a direction with a primarily radial component.

In one embodiment, the needle is arranged to move axially to causeseparation of the tube distal flange from the retainer.

In one embodiment, the retainer comprises recesses for retaining wingsof a winged tube distal flange. In one embodiment, the retainer isconfigured to adhere or lock to the distal flange up to a thresholdaxial force during withdrawal of the needle. Preferably, the applicatorcomprises a stop surface to stop axial movement of a tube proximalflange, the retainer squeezing the tube against the stop surface tocause the distal flange to release. In one embodiment, the stop surfaceis on the sleeve into which the needle is inserted.

In one embodiment, the retainer includes a discrete component on theneedle. In one embodiment, the discrete component is of plasticsmaterial.

In one embodiment, the component has a through-hole through which aneedle stem extends, and the component is in contact with the needletip.

In one embodiment, the retainer is arranged to retain the distal flangein the pre-deployment folded configuration by at least adhesive.

In one embodiment, the retainer is arranged to retain the distal flangein the pre-deployment folded configuration by at least mechanicalengagement.

In one embodiment, the retainer comprises fingers engaging eyelets onthe tube distal flange. In one embodiment, the retainer comprisesdovetail or slot features for engagement with a tube distal flange.

In one embodiment, the retainer is adapted to engage with a tube bywelding or magnetism for retaining the distal flange in the foldedconfiguration.

In one embodiment, the applicator further comprises a tympanostomy tubehaving a proximal flange, a shank, and a distal flange, in which saidtube is mounted on the needle with said distal flange folded andretained in said folded position by the retainer.

In one embodiment, the applicator is a cartridge for attachment to ahandle with a mechanism for movement of said needle.

In one embodiment, the applicator further comprises an integral handlewith a mechanism for movement of the needle.

In another aspect, the invention provides a tympanic tube comprising aproximal flange, a bridge, a distal flange, and a lumen, wherein thedistal flange is configured to be retained at a folded orientation witha direction having a primarily axial component and to release to adeployed position having a direction with a primarily radial componentupon movement of the needle.

In one embodiment, the distal flange comprises a plurality of wings. Inone embodiment, the distal flange has an angle to axial in the foldedposition in the range of 0° to +/−20°.

In one embodiment, the distal flange has an angle to axial in theunconstrained deployed position in the range of 40° to 140°. In oneembodiment, the bridge is of a material which is resilient to allow aneedle tip of larger diameter than the lumen to pass through.

In one embodiment, the distal flange has two wings. In one embodiment,the distal flange has three wings. In one embodiment, the distal flangehas four wings.

In one embodiment, the distal flange is annular-shaped, optionally withradial cut-outs.

In one embodiment, the distal flange comprises at least one mechanicalengagement part arranged to engage mechanically a needle retainer, andeach mechanical engagement part may be an eyelet for receiving aretainer part or a tab for engagement behind or within a slot or eyeletof the retainer.

In one embodiment, the distal flange includes an insert of a materialwhich is different from surrounding material, said insert beingconfigured for attachment to a retainer by, for example, welding,magnetism, or adhesive.

In another aspect, the invention provides a method of deploying atympanostomy tube across a tympanic membrane, in which:

the tube comprises a proximal flange, a bridge, a distal flange, and alumen, the method is performed with an applicator comprising a needlewith a stem and a tip, and the needle being movable, the tube is mountedon the needle with the needle stem through the tube lumen, and the tubedistal flange is retained in a folded position to have a primarily axialcomponent facing distally;

-   -   the method comprising the steps of:

piercing the tympanic membrane with the needle tip and locating theneedle so that the tube distal flange is distal of the membrane and thetube bridge passes through the membrane, moving the needle relative tothe tube to cause separation of the tube distal flange from the needle,freeing the distal flange to spring out on a radial orientationunconstrained.

In one embodiment, the needle is moved axially to release the distalflange. In one embodiment, the needle movement is in the proximaldirection.

In one embodiment, the tube distal flange is adhered to or mechanicallyengaged with a retainer on the needle.

In one embodiment, the needle movement is rotational.

In one embodiment, the tube distal flange is retained by one or more ofan adhesive, mechanical engagement, welding, and magnetism.

DETAILED DESCRIPTION OF THE INVENTION Brief Description of the Drawings

The invention will be more clearly understood from the followingdescription of some embodiments thereof, given by way of example onlywith reference to the accompanying drawings in which:—

FIG. 1 is an exploded perspective view of the distal end of atympanostomy tube applicator of the invention together with a tube inits deployed configuration;

FIGS. 2(a), 2(b) and 3 to 6 are diagrams illustrating a sequence ofsteps for deployment of the tube using the applicator from a position atwhich the inner flange is near axial to radial as shown in FIG. 1;

FIG. 7 is a perspective view of the distal end of an alternativeapplicator, in which a tube has an inner or “distal” flange with twowings;

FIGS. 8 to 12 are perspective views of alternative tubes which could bedeployed using applicators of various embodiments, the tubes being shownin their deployed configurations;

FIG. 13 is an exploded perspective view of an alternative applicatoralong with a tube in its manufactured configuration, in which case thetube mechanically engages the retainer before deployment;

FIG. 14 is a perspective view showing the applicator of FIG. 13 beforedeployment and

FIG. 15 is perspective view of the applicator in use with the needlebeing retracted causing in situ changing of the shape of the tube from aconfiguration with a distal flange being near axial to being radial tofully engage behind the tympanic membrane;

FIG. 16 is a perspective view of an alternative tube in its deployedconfiguration, this tube having an alternative arrangement formechanically engaging the retainer before deployment;

FIG. 17 is a perspective view showing an applicator and a tube in itsas-manufactured configuration, in which case there is a furtheralternative arrangement for mechanical engagement of the tube distalflange with the retainer, and FIG. 18 shows the applicator with the tubein its final configuration with mechanical tabs removed

FIG. 19 is a perspective view of the distal end of an alternativeapplicator of the invention in this case involving welding;

FIG. 20 is a perspective view of a tube in its as-manufactured shape,with holes in distal flange wings for magnetic inserts or inserts forwelding material; and

FIGS. 21 and 22 are a perspective view and a longitudinal sectional viewof an alternative tube, FIG. 23 is a side view showing the tubeassembled as part of an applicator before deployment, and FIG. 24 is aperspective view showing the tube after deployment as the applicator'sneedle is withdrawn.

DESCRIPTION OF THE EMBODIMENTS

Referring to FIG. 1 a tympanostomy tube applicator or placement deviceis for connection to a handle with a needle pull-through mechanism topull a needle proximally in an action with a desired force could beused.

The placement device comprises a single-use cartridge replaceablyconnected to such a handle, and the cartridge has a distal end as shownin FIG. 1. The cartridge comprises a stem 2 with a distal end 3 to abutthe proximal flange of a tympanostomy tube 20 to be deployed. Theplacement device is provided as a component to fit onto any desiredmechanism to pull a needle axially, preferably spring-operated. Forexample, the handle may have a manually-operated latch which releases aspring to allow withdrawal of the needle under spring force. Such typesof mechanisms are well known, even for household items such as writingpens.

A pull-through needle comprises a needle stem 6, a distal tip 7 ofconical shape, and a moulded plastics tube retainer 5 held in place onthe stem by a small flange 8 on the stem. The retainer may in otherembodiments be of metal, and indeed may be integral with the stem. Theretainer 5 is snap-fitted distally of the flange 8 and against the tip7. The retainer 5 comprises a cylindrical base 10 and a tapered distalportion 11 with slots 12 to receive and retain folded wings 23 of adistal flange of the tube 20 when the retainer is within the distal endof the tube 20. Referring particularly to FIG. 1 the tube 20 comprises:

-   -   a proximal flange 21 shaped to abut the distal end 3 of the stem        2,    -   a central shank or bridge 22,    -   a distal flange 23 comprising four orthogonally-arranged wings        24, and    -   a lumen 25.

The view of the tube 20 is its post-deployment configuration.Pre-deployment, the distal flange 23 is folded to lie axially as shownin FIG. 2.

The lumen 25 extends through the tube 20, with a cross-sectional areasuited to the intended use of balancing pressure across the tympanicmembrane of the specified patient age group.

FIGS. 2(a) and 2(b) show the tube 20 before deployment, with the wings23 folded to lie within, and adhered to, the recesses 12 of the retainer5. At this position the wings 23 have a small angle to axial of about 0°to +/−20°, and the retainer is radially within the distal flange.

The tube wings 24 are of a more pliable material than the shank 22 andthe proximal flange 21. This is achieved by co-moulding in anover-moulding process whereby the shank 22 can be made of a more rigidmaterial than the wings 24.

After moulding of the tube 20 the manufacturer completes the cartridgeby adhering the wings 24 into the recesses 12 using a suitable approvedadhesive for medically invasive use. The wings 24 are therefore pulledfrom within into the axial orientation. The combined retainer 5 and tube20 are slid along the needle stem 6, which is then inserted into thecartridge stem 2 lumen. This operation is complete when the needle'sproximal end is in position to engage a handle drive mechanism, and thetube proximal flange 21 is against the face 3. The retainer 5 issnap-fitted onto the needle stem 6 as described above.

Deployment requires the surgeon to cause the needle tip 7 to pierce thetympanic membrane and move it until the distal flange wings 24 are atthe inner (distal) side of the membrane. The handle drive mechanism isactivated to pull the needle 4 through, causing (FIG. 3) the wings 24 tobuckle until the adhesive breaks. This releases the pulling action ofthe needle's retainer on the wings, and so they are released to springto the radial position (FIG. 4). The needle is then fully withdrawn(FIGS. 5 and 6).

This leaves the tube 20 in situ bridging the patient's tympanicmembrane. It is noted that the tube shank or bridge 22 needs to deformbecause the tip 7 is wider than the lumen 24. So, while the shank 22needs to be of a more rigid material than the distal flange 23, it doesneed sufficient resilience for this pull-through action. In order forthe tube material not to cause too much force on the system so that theneedle can successfully retract and release the tube distal flange, thematerial in the lumen needs to be flexible enough so that it does notincrease the force on the needle retracting but is rigid enough to stillhold its shape while implanted in the membrane.

In other embodiments the needle tip fits within the lumen of the tube,and so distortion of the tube's bridge is not required.

In this case the distal flange 23 use position is about 90° to axial,however it may more generally be in the range of 40° to 140° (see FIG.12 for example), depending on the application.

It will be appreciated that the applicator allows very simple andeffective tube deployment, while the distal flange is wide enough for along dwell time of 15 to 24 months for example.

FIG. 7 shows an applicator with a stem 45, a needle 47 and a retainer48. In this case a tube 40 has a proximal flange 41, a shank 42, and adistal flange 43 formed by two diametrically opposed wings 43 pulledradially inwardly by being adhered to sockets of the retainer 48.

In other embodiments the tube has a different number of wings. FIG. 8illustrates a tube 50 with a proximal flange 51, a shank 52, and adistal flange 53 with three wings 54 equi-spaced around a lumen 55. Theapplicator has a retainer configured with slots to adhere to the threewings.

FIG. 9 shows a tube 60 having a proximal flange 61, a shank 62, and adistal flange 63 having two diametrically opposed wings 64. Thisarrangement is known generally as a “T-tube”, being particularlysuitable for long dwell times, greater than 18 months, due to the lengthof the wings. In this embodiment the tube 60 has the overallconfiguration and use characteristic of such a T-tube, but the distalflange materials are suitable for lying axially while adhered to theapplicator tip before deployment.

It will be appreciated that the placement device, by pulling the distalflange into axial alignment pre-deployment, allows independence ofdistal flange diameter from deployment considerations. This allowsexcellent versatility.

FIG. 10 shows a tube 70 having a proximal flange 71, a shank 72, and adistal flange 73 which is disc-shaped with two opposed notches 74 toprovide flexibility for deployment. If the distal flange material ismore flexible, it may be completely ring-shaped, without notches whichare to aid folding onto the insert.

FIG. 11 shows such a tube 80, having a proximal flange 81, a shank 82,and a distal flange 83. In this case the distal flange 80 is fullyannular in shape, the pre-deployment folding being achieved entirely dueto flexibility of the flange material.

FIG. 12 shows a tube 90 with a proximal flange 91, a shank 92, and adistal flange 93 in a bevelled configuration at an acute angle to axial.There are four wings 94. This tube is suitable for long stay times. Thebevelled configuration can aid folding the inner flanges onto theinsert.

Referring to FIG. 13 a placement device 100 comprises a stem 102 and aneedle 104 with a stem 106, a tip 107, and retainer snap fit dimples 108on the stem. A retainer 105 comprises a base 110 and a castellateddistal end 113 with four axially-extending fingers 114. In otherembodiments however there may be a different number of fingers. A tube120 is shown, for clarity, in FIG. 13 with its distal flange extendinglaterally, even though it is supplied with the flange near axial on theretainer 105. The tube 120 comprises:

-   -   a proximal flange 121;    -   a shank or bridge 122;    -   a distal flange 123, with four equally-spaced wings 124 each        having an outer eyelet 125; and    -   a lumen 126 through the bridge and the flanges.

As shown in FIGS. 14 and 15, in this case the tube 120 distal flange 123is pulled radially inwardly into the axial position to be retained bymechanical engagement with the retainer 105. In this case the mechanicalengagement is achieved by the four eyelets 125 being engaged with theretainer fingers 114, each finger 114 extruding axially through aneyelet 125. The eyelets 125 have a degree of flexibility so that theycan extend radially inwardly to engage the fingers 114, as shown in FIG.14. The materials of the eyelets 125 are of an elastic material toextend over the fingers for assembly.

As the needle tip 107 is pulled through, it causes the eyelets 125 toshear during the retraction of the needle into the cartridge. Theremainder of the tube is of a tougher material and thus the elasticmaterial of the tube's eyelets 125 is sheared. This sheared materialwill be retracted into the cartridge under the needle tip. This providesthe configuration shown in FIG. 15, the tube being deployed with adistal flange having four wings 124.

It is envisaged that different forms of mechanical locking or engagementmay be employed. For example, FIG. 16 shows a tube 220 having:

-   -   a proximal flange 221;    -   a shank 222; and    -   a distal flange 223 with tabs 224 having a neck and a head which        engage with a corresponding female feature of the retainer.

Referring to FIGS. 17 and 18 an alternative placement device 250 has astem 252, and a needle 254 with a stem 256, a tip 257, and retainersnap-fit dimples 258. A retainer 255 in this case comprises a maincylindrical body 260 and axially-directed fingers 261 defining axialslots 262 between them. A tube 270, shown in FIG. 17 in itsas-manufactured configuration, has a proximal flange 271, a bridge orshank 272, and a distal flange 273 with flanges 274 having tabs 275. Thetabs 275 have heads for engaging behind the slots 262 when the wings 274are axially, the tabs 275 extending radially inwardly. FIG. 18 shows thetube 270 after deployment, when the retainer fingers 261 (still shownhere in the distal position) have been pulled proximally to shear thetabs 275 from the wings 274.

In other embodiments, the distal flange is temporarily attached to theretainer by way of welding. For example, referring to FIG. 19 aplacement device cartridge 300 has a stem 302 and a needle with aretainer 305 and a tip 307. A tympanostomy tube 320 is attached to theretainer 305 to have the same configuration as in other embodiments.However, in this case the attachment is by way of welding. The tube 320comprises a proximal flange 321, a bridge 322, and a distal flange 323formed by four wings 324. Each wing 324 has a spot weld 326 totemporarily affix it to the retainer 305, until they are detached by theneedle tip 307 being pulled through as in some of the other embodiments.

FIG. 20 shows the tube 320 of FIG. 19 as manufactured, with an aperture325 for insertion of material which is more susceptible to welding. Inother embodiments this may be for insertion of material which ismagnetic. Of course, insertion of the material is preferably done duringmanufacture.

The spot weld may be performed on a chosen part of the wing 324, thewings each being of an homogenous construction. Alternatively, some orall wings may have a discrete portion suitable for welding by havingdifferent characteristics, such as for example having an insert of adifferent material which is more suitable for welding and/or being of adifferent thickness. The welding may for example be ultrasonic. Wherethere are inserts, they may be of a metalized material or plasticsmaterial and the welding may be laser or ultrasonic welding.

Referring to FIGS. 21 and 22 a tube 400 has a proximal flange 401, abridge or shank 402 with a lumen 403, and a distal flange 404. Thelatter comprises a set of four tabs at 90° separations, and at theradial end of each tab 405 there is an eyelet 406 with an aperture 407which engages a needle, The tube 400 is two-part, having a Titanium part410 providing the proximal flange and the bridge, and a flexible andresilient plastics part 411 providing the distal flange. The distal endof the Titanium part 410 comprises a bevel 412 having a distal edge 413to which the distal flange 404 is over-moulded.

The distal end of a placement device 420 is shown in FIG. 23, in whichthe eyelets 406 engage the needle stem behind (proximally of) the tip.The four eyelets 406 form a four-layer sandwich between the needle tip422 and the edge 413 of the bridge. The different axial distances arepossible because the material of the plastics part 411 is resilient.However, it is envisaged that in other embodiments the distal flangetabs may be of different lengths, the longest one engaging the stem atthe furthest location distally.

As the needle is withdrawn the four layers (made up of the distal tabs405 and 406) are squeezed and cut by the rear edge of the needle tip 422and the edge 413.

The final configuration of the tube 400 is shown in FIG. 24, as theneedle 422 is retracted further. Advantageously, the sheared eyelets arefully engaged with the needle stem and so there is no risk that theywill remain in situ after surgery.

In other embodiments the distal flange may have wings with metallicinserts for magnetic attachment to the needle and/or retainer. Theretainer would be made from a magnetised metal so that the magnets onthe flange of the tube would attach to it.

The invention is not limited to the embodiments described but may bevaried in construction and detail. For example, the needle may have alumen, thereby allowing delivery of fluids for aspiration.

The placement device may be arranged so that the tube separates byrotation of the needle rather than pull-through. In this case the wingsare not adhered into sockets, rather to a retainer/needle surface whichis not recessed. The rotation of the needle causes the wings to bedetached from the retainer and forming its deployed configuration.

It is not essential that the placement device have a separable handleand cartridge. They may be integrated. In this case, the needle issingle-use.

Where there is a pull-through arrangement, this could be achieved by anysuitable drive arrangement, such as a push-button drive of the type usedfor a retractable pen, or a motorised arrangement.

It is also envisaged that the distal flange may be retainedmechanically, in an arrangement other than those illustrated. Furtherexamples are a press fit feature, or different mechanical features tolock the wings in place.

Features of embodiments described above may be interchanged across otherembodiments as would be appreciated by those skilled in the art. Forexample the embodiment of FIGS. 13 to 15 may be modified to have aretainer and tube configured with a different number of flange wings andretainer fingers.

Also, the retainer may be of metal material rather than plastics, and itmay be integral with the needle stem. Also, it is not essential thatthere be a snap-fit feature to hold the retainer on the needle stem.Also, the retaining may be performed by any or some of adhesive,mechanical engagement, welding, and magnetism.

1.-38. (canceled)
 39. A tympanostomy tube applicator comprising: aneedle with a tip and a stem, and a retainer on the needle stem, whereinthe retainer is configured to fit within and retain a tympanostomy tubedistal flange in a folded configuration having a direction with aprimarily axial component such that movement of the needle tip causesthe distal flange to release from the retainer to a deployed positionhaving a direction with a primarily radial component, wherein the needleis arranged to move axially to cause release of the tube distal flangefrom the retainer.
 40. The tympanostomy tube applicator as claimed inclaim 39, wherein the retainer comprises recesses for retaining wings ofa winged tube distal flange.
 41. The tympanostomy tube applicator asclaimed in claim 39, wherein the applicator comprises a stop surface tostop axial movement of a tube proximal flange, such that the retainersqueezes the tube against the stop surface to cause the distal flange torelease during axial movement of the needle in the proximal direction.42. The tympanostomy tube applicator as claimed in claim 39, wherein theapplicator comprises a stop surface to stop axial movement of a tubeproximal flange, such that the retainer squeezes the tube against thestop surface to cause the distal flange to release during axial movementof the needle in the proximal direction; and wherein the stop surface ison a sleeve into which the needle is inserted.
 43. The tympanostomy tubeapplicator as claimed in claim 39, wherein the retainer includes adiscrete component on the needle; and wherein the retainer discretecomponent has a through-hole through which the needle stem extends, andthe component is in contact with the needle tip.
 44. The tympanostomytube applicator as claimed in claim 39, wherein the retainer is arrangedto retain the distal flange in the pre-deployment folded configurationby at least adhesive.
 45. The tympanostomy tube applicator as claimed inclaim 39, wherein the retainer is arranged to retain the distal flangein the pre-deployment folded configuration by at least mechanicalengagement; and wherein the retainer comprises fingers engaging eyeletson the tube distal flange; and wherein the retainer comprises dovetailor slot features for engagement with a tube distal flange.
 46. Thetympanostomy tube applicator as claimed in claim 39, wherein theretainer is adapted to engage with a tube by welding or magnetism forretaining the distal flange in the folded configuration.
 47. Thetympanostomy tube applicator as claimed in claim 39, further comprisinga tympanostomy tube having a proximal flange, a bridge with a lumen, anda distal flange, in which said tube is mounted on the needle with theneedle stem extending through the lumen and with said distal flangefolded and retained in said folded position by the retainer.
 48. Thetympanostomy tube applicator as claimed in claim 39, wherein theapplicator is a cartridge for attachment to a handle with a mechanismfor movement of said needle; or wherein the applicator further comprisesan integral handle with a mechanism for movement of the needle.
 49. Atympanostomy tube comprising a proximal flange, a bridge, a distalflange, and a lumen, wherein the distal flange is configured to beretained at a folded orientation with a direction having a primarilyaxial component and to release to a deployed position having a directionwith a primarily radial component upon movement of a retainer locatedradially within the distal flange; wherein the distal flange comprises aplurality of wings; wherein the distal flange has an angle to axial inthe folded position in the range of 0° to +/−20°; and wherein the distalflange has an angle to axial in the unconstrained deployed position inthe range of 40° to 140°.
 50. The tympanostomy tube as claimed in claim49, wherein the bridge is of a material which is resilient to allow aneedle tip of larger diameter than the lumen to pass through.
 51. Thetympanostomy tube as claimed in claim 49, wherein the distal flangecomprises at least one mechanical engagement part arranged to engagemechanically a needle retainer, and each mechanical engagement partcomprises an eyelet for receiving a retainer part or a tab forengagement behind or within a slot or and eyelet of the retainer. 52.The tympanostomy tube as claimed in claim 49, wherein the distal flangeincludes an insert of a material which is different from surroundingmaterial, said insert being configured for attachment to a retainer by,for example, welding, magnetism, or adhesive.
 53. A method of deployinga tympanostomy tube across a tympanic membrane, in which: the tubecomprises a proximal flange, a bridge, a distal flange, and a lumen, themethod is performed with an applicator comprising a needle with a stemand a tip, and a retainer on the needle stem, the tube is mounted on theretainer with the needle stem through the tube lumen, and the tubedistal flange is retained in a folded position to have a primarily axialcomponent facing distally; the method comprising the steps of: piercingthe tympanic membrane with the needle tip and locating the needle sothat the tube distal flange is distal of the membrane and the tubebridge passes through the membrane, moving the retainer relative to thetube to cause separation of the tube distal flange from the retainer,freeing the distal flange to spring out on a radial orientationunconstrained.
 54. The method of deploying a tympanostomy tube asclaimed in claim 53, wherein the needle is moved axially in the proximaldirection to release the distal flange.
 55. The method of deploying atympanostomy tube as claimed in claim 53, wherein the tube distal flangeis adhered to a retainer on the needle; and wherein an adhesive bond isbroken during needle withdrawal.
 56. The method of deploying atympanostomy tube as claimed in claim 53, wherein the tube distal flangein retained at least by mechanical engagement.
 57. The method as claimedin claim 53, wherein the tube distal flange includes parts whichmechanically engage the retainer and/or the needle and are sheared uponretraction of the needle.
 58. The method as claimed in claim 53, whereinthe applicator comprises a stop surface to stop axial movement of a tubeproximal flange, such that the retainer squeezes the tube against thestop surface to cause the distal flange to release during axial movementof the needle in the proximal direction; and wherein said parts includeeyelets.